BRIEF—FDA approves yet another indication for Keytruda

The US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab), Merck & Co’s mega-blockbuster anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.

The approval is based on data from the Phase III KEYNOTE-A18 trial, in which Keytruda plus CRT demonstrated an improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 41% (HR=0.59 [95% CI, 0.43-0.82]) compared to placebo plus CRT in patients with FIGO 2014 Stage III-IVA disease. Median PFS was not reached in either group.

This approval marks the third indication in cervical cancer and the 39th indication in the USA for Keytruda, which notched up first-half 2023 global sales of $12.1 billion.